USP 795 Nonsterile Compounding Record and Beyond-Use Dating
Record each nonsterile compounding event, document ingredients and checks, and assign a beyond-use date using the USP 795 water-activity framework.
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Built for: Pharmacy · Healthcare · Compounding Pharmacy
Overview
This template is a batch record for nonsterile compounding events that also documents how the beyond-use date was assigned. It brings together the preparation name, dosage form, batch or lot reference, master formula reference, ingredient table, equipment used, compounding method, water activity measurement, and final quality sign-off in one place.
Use it when you need a repeatable record for a compounded preparation and you want the BUD rationale tied to the actual batch conditions, not a guess. It is especially useful for formulations where water activity affects stability and storage decisions. The form also supports review of deviations or incidents, which helps preserve the audit trail and makes later investigation easier.
Do not use this as a generic intake form or for sterile compounding workflows that require different controls. It is also not the right fit if you are not documenting a real batch event, if you do not need a beyond-use date, or if your process cannot support the required measurements and review steps. Keep the record focused on the minimum necessary data: only collect what you need to identify the batch, verify the formula, justify the BUD, and confirm final release.
Standards & compliance context
- The form supports USP 795-style documentation by linking the batch record to a documented beyond-use date basis.
- Using structured fields for ingredients, measurements, and sign-off helps maintain an audit trail and reduces ambiguity in review.
- The template follows the minimum-necessary principle by focusing on batch data rather than collecting unrelated personal information.
- If any PII is collected for preparer or reviewer identification, the form should include a clear disclosure and limit collection to what is needed for accountability.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Compounding Event Details
This section anchors the record to one specific batch so the preparation can be traced, reviewed, and reproduced if needed.
- Record Date
- Compounding Date
- Compounding Time
- Preparation Name
- Dosage Form
-
Batch or Lot Reference
Internal batch identifier or compounding reference number for the audit trail.
-
Intended Use
Briefly describe the clinical or dispensing purpose. Collect only what is needed for the record.
Formula and Ingredients
This section shows exactly what went into the batch and how it was prepared, which is essential for verification and auditability.
- Master Formula Reference
- Ingredients
- Equipment Used
-
Compounding Method
Describe the method used, including any mixing, heating, levigation, or dilution steps.
Water Activity and Beyond-Use Date
This section documents the measurement or basis used to justify the BUD, which is the core decision point for release and storage.
- Was Water Activity Measured?
-
Water Activity Value (aw)
Enter the measured water activity value if available.
- Water Activity Method
- Assigned Beyond-Use Date
- BUD Assignment Basis
-
BUD Rationale
Explain how the beyond-use date was determined, including any water-activity result, formulation characteristics, and supporting references.
Quality Checks and Sign-Off
This section confirms the batch was inspected, labeled correctly, and reviewed before it leaves the compounding workflow.
- Final Inspection Completed
- Label Verified
-
Deviations or Incidents
Document any deviations, errors, or corrective actions. Leave blank if none.
- Preparer Name
-
Reviewer Name
If your workflow requires review, record the reviewer here.
- Signature
Compliance and Disclosure
This section captures acknowledgement of any PII notice and the final submit confirmation so the record has a clear completion point.
- I understand this form collects limited personnel and compounding record information for quality, compliance, and audit trail purposes.
- What happens after I submit
How to use this template
- Enter the compounding event details first, including the record date, compounding date and time, preparation name, dosage form, batch or lot reference, and intended use.
- Select or link the master formula reference, then list each ingredient with the correct field type and note the equipment and compounding method actually used.
- Record the water activity measurement, method, and value, or document why a measurement was not taken if your workflow allows that exception.
- Assign the beyond-use date and write a clear BUD basis and rationale that matches the measured data, formula reference, and any stability assumptions used.
- Complete the final inspection, verify the label, capture any deviations or incidents, and obtain preparer and reviewer sign-off before release.
Best practices
- Use date pickers, numeric inputs, and multi-select fields where appropriate so the record is easy to complete and easy to audit.
- Keep required fields limited to the information needed to identify the batch, justify the BUD, and confirm release.
- Document the water activity method and value at the time of compounding, not after the batch has already been dispensed.
- Use conditional logic to show dosage-form-specific fields only when they apply, instead of forcing every user through the same long form.
- Record deviations in plain language and tie them to the affected ingredient, step, or label so reviewers can assess impact quickly.
- Require reviewer sign-off before the batch is released, especially when the BUD depends on measured data or a nonstandard formula.
- Keep the ingredient table aligned with the master formula so substitutions and lot changes are visible during review.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What is this template used for?
This template documents a single nonsterile compounding event from recipe reference through final sign-off. It captures the preparation details, ingredient list, equipment, water activity data, and the beyond-use date basis used for the batch. Use it when you need a repeatable record tied to USP 795-style compounding workflows.
Is this for every compounded preparation or only certain ones?
Use it for nonsterile compounded preparations where you need a batch record and a documented beyond-use date. It is especially useful when the formulation depends on water activity or other stability factors that affect shelf life. If your process does not require a formal compounding record, a lighter intake or log may be enough.
Who should complete and review this form?
The preparer should complete the formula, ingredient, and process fields at the time of compounding, while a pharmacist or designated reviewer should verify the final inspection, label, and beyond-use date basis. The reviewer should also confirm any deviations or incidents are documented before sign-off. This split helps create a clear audit trail.
How often should this form be used?
Complete one record for each compounding event or batch, not as a monthly summary. That keeps the record tied to the exact ingredients, method, and water activity result used for that preparation. If a batch is repeated later, create a new form rather than reusing an older record.
What should I enter for the beyond-use date basis?
Use the field to explain whether the beyond-use date came from measured water activity, the master formula, stability data, or another documented basis. The rationale should be specific enough that another reviewer can see why that date was chosen. Avoid vague entries like "per policy" without the underlying basis.
What are the most common mistakes when using this template?
Common issues include leaving the ingredient table incomplete, entering free-text dates where a date field should be used, and failing to document deviations from the master formula. Another frequent mistake is assigning a beyond-use date without recording the water activity method or value. The form works best when every required field is completed at the time of the event.
Can this template be customized for different dosage forms or workflows?
Yes. You can add conditional logic for capsules, creams, oral liquids, or other dosage forms so only relevant fields appear. You can also adjust the ingredient table, equipment list, and review steps to match your pharmacy workflow while keeping the core record intact.
Does this template support audit trails and electronic review?
Yes, if your system stores timestamps, signatures, and field history, the form can support an audit trail for each batch. It also works well with approval workflows so preparer and reviewer actions are captured separately. If you integrate it with inventory or label systems, keep the source-of-truth fields in one place to avoid mismatches.
How does this compare with an ad-hoc spreadsheet or paper log?
A structured template reduces missing fields, inconsistent beyond-use date logic, and unclear sign-off responsibility. It also makes it easier to standardize water activity documentation and review deviations across batches. Ad-hoc logs can work for very small operations, but they are easier to misread and harder to audit.
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